Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects
NCT ID: NCT01129388
Last Updated: 2011-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2009-03-31
2009-05-31
Brief Summary
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* Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects
Secondary Objectives:
* Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval
Detailed Description
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* Screening: 2 to 21 days before the first dosing
* Period clopidogrel/placebo: 7 days including 5 days treatment
* Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
* Washout between periods: at least 14 days period after last dosing respect to clopidogrel treatment
* End of study: at 7 to 10 days after the last dosing
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Group clopidogrel - clopidogrel + omeprazole
Period 1:
* Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions
* Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily
Period 2:
* Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily
* Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
* Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily
clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration:oral
Group placebo - placebo + omeprazole
Period 1:
* Day 1: placebo loading dose in the morning under fasted conditions
* Day 2 to Day 5: placebo in the morning under fasted conditions, once daily
Period 2:
* Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily
* Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
* Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration:oral
Group clopidogrel + omeprazole - clopidogrel
Period 1:
* Day -5 to Day -1: omeprazole 80 mgin the evening 2 hours after dinner, once daily
* Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
* Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily
Period 2:
* Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions
* Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily
clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration:oral
Group placebo + omeprazole placebo
Period 1:
* Day -5 to Day -1: omeprazole 80 mg, once daily in the evening 2 hours after dinner
* Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
* Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily
Period 2:
* Day 1: placebo loading dose in the morning under fasted conditions
* Day 2 to Day 5: placebo in the morning under fasted conditions, once daily
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration:oral
Interventions
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clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration:oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* as determined by medical history, physical examination including vital signs and clinical laboratory tests.
* with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²
Exclusion Criteria
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
* Any contraindication to clopidogrel and/or omeprazole
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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International Clinical Development Study Director
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Countries
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References
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Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011 Jan;89(1):65-74. doi: 10.1038/clpt.2010.219. Epub 2010 Sep 15.
Other Identifiers
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INT11166
Identifier Type: -
Identifier Source: org_study_id